Status:
COMPLETED
Review of Safety Using Rilonacept in Preventing Gout Exacerbations (RE-SURGE)
Lead Sponsor:
Regeneron Pharmaceuticals
Conditions:
Gout
Eligibility:
All Genders
18-80 years
Phase:
PHASE3
Brief Summary
The purpose of this clinical research study is to determine the safety and effectiveness of an experimental drug called rilonacept in subjects with gout who are on urate-lowering therapy. Subjects wil...
Eligibility Criteria
Inclusion
- Male or female 18 to 80 years of age;
- Previously met the preliminary criteria of American Rheumatism Associatio (ARA) for the classification of acute gout arthritis of primary gout;
- Subjects with history of gout, initiating or currently on urate lowering; therapy who are at risk of gout flare.
Exclusion
- Acute gout flare within 2 weeks prior to the screening visit and during the screening visit;
- Persistent chronic or active infections;
- History of an allergic reaction to allopurinol;
- History or presence of cancer within 5 years of the Screening Visit;;;
Key Trial Info
Start Date :
March 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 1 2011
Estimated Enrollment :
1315 Patients enrolled
Trial Details
Trial ID
NCT00856206
Start Date
March 1 2009
End Date
January 1 2011
Last Update
April 28 2017
Active Locations (124)
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1
Alabaster, Alabama, United States
2
Mesa, Arizona, United States
3
Burbank, California, United States
4
Long Beach, California, United States